510(k) K250016
K250016 is an FDA 510(k) premarket notification submitted by Htl-Strefa S.A for the device "droplet® personal lancets". The FDA issued a decision of Substantially Equivalent on July 1, 2025. The device falls under product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature), a Class II device regulated under 21 CFR 878.4850. Htl-Strefa S.A has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 2025
- Date Received
- January 3, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- Device Class
- Class II
- Regulation Number
- 878.4850
- Review Panel
- SU
- Submission Type
A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.